ETHYOL- amifostine injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMIFOSTINE (UNII: M487QF2F4V) (AMIFOSTINE ANHYDROUS - UNII:ILA426L95O)

Available from:

Clinigen Limited

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies (14.1)] . ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see Clinical Studies (14.2)] . Limitation of Use Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure [see Warnings and Precautions (5.1)] , or in patients receiving definitive radiotherapy [see Warnings and Precautions (5.2)] , except in the context of a clinical study. ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds. When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for pregnancy information. Based on findings in animals, ETHYOL can cause fetal harm when administered to a pregnant woman. There are no available data on ETHYOL use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of ETHYOL to pregnant rabbits during organogenesis was embryotoxic at doses approximately sixty percent of the recommended dose in humans based on body surface area (see Data) . Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies in the U.S. general population. ETHYOL has been shown to be embryotoxic in rabbits at intravenous doses of 50 mg/kg, approximately sixty percent of the recommended dose in humans on a body surface area basis. When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for lactation information. There are no data on the presence of amifostine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with ETHYOL. When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for contraception and infertility information. Verify pregnancy status in females of reproductive potential prior to initiating ETHYOL. Males Based on findings from animal studies, ETHYOL may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)]. The safety and effectiveness in pediatric patients have not been established. The clinical studies did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients.

Product summary:

ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized white powder in 10 mL single-dose vials (NDC 76310-017-50). Each vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows: Carton containing 3 vials (NDC 76310-017-50) Discard unused portion. Store the lyophilized dosage form at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Follow special handling and disposal procedures [see References (15)].

Authorization status:

New Drug Application

Summary of Product characteristics

ETHYOL- AMIFOSTINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CLINIGEN LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ETHYOL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ETHYOL.
ETHYOL (AMIFOSTINE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
ETHYOL is a cytoprotective agent indicated for:
reduction of cumulative renal toxicity associated with repeated
administration of cisplatin in patients
with advanced ovarian cancer. (1.1)
reduction of the incidence of moderate to severe xerostomia in
patients undergoing post-operative
radiation treatment for head and neck cancer, where the radiation port
includes a substantial portion of
the parotid glands. (1.2)
Limitation of Use
Avoid the use of ETHYOL in settings where chemotherapy can produce a
significant survival benefit or cure,
or in patients receiving definitive radiotherapy. (1, 5.1, 5.2)
DOSAGE AND ADMINISTRATION
For reduction of cumulative renal toxicity with chemotherapy, the
recommended starting dose is 910
mg/m administered once daily as a 15-minute intravenous infusion,
starting 30 minutes prior to
chemotherapy. (2.1)
For reduction of moderate to severe xerostomia from radiation of the
head and neck, the
recommended dose is 200 mg/m administered once daily as a 3-minute
intravenous infusion, starting
15-30 minutes prior to standard fraction radiation therapy (1.8-2.0
Gy). (2.2)
DOSAGE FORMS AND STRENGTHS
For injection: sterile lyophilized powder in 10 mL single-dose vials.
Each vial contains 500 mg of amifostine on the anhydrous basis.
CONTRAINDICATIONS
ETHYOL is contraindicated in patients with known hypersensitivity to
aminothiol compounds. (4)
WARNINGS AND PRECAUTIONS
Hypotension and Cardiovascular Events: Patients who are hypotensive or
dehydrated should not
receive ETHYOL. If interruption of antihypertensive therapy is
possible, interrupt antihypertensive
therapy 24 hours prior to ETHYOL administration. Monitor blood
press